CIOS ALPHA
FDA 510(k) clearance K132094 · decided 2014-03-11
Clearance details
- K-number
- K132094
- Device name
- CIOS ALPHA
- Applicant
- Siemens Medi Cal Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-08
- Decision date
- 2014-03-11
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mavern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - recall (Z-2848-2020) | Siemens Medical Solutions USA, Inc | 2020-08-22 |
| Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging o recall (Z-0782-2020) | Siemens Medical Solutions USA, Inc | 2020-01-07 |
| Cios Alpha, mobile X-ray system recall (Z-1278-2016) | Siemens Medical Solutions USA, Inc | 2016-03-31 |
| Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of t recall (Z-1958-2015) | Siemens Medical Solutions USA, Inc | 2015-07-02 |